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四周食用猪胶原蛋白水解物对超重或肥胖男性和女性的血糖浓度、血糖变异性以及空腹/餐后心脏代谢风险标志物的影响:一项随机对照试验。

Effects of four-weeks porcine-collagen hydrolysate consumption on glucose concentrations, glycemic variability, and fasting/postprandial cardiometabolic risk markers in men and women with overweight or obesity: A randomized, controlled trial.

作者信息

Chavez-Alfaro Marco A, Mensink Ronald P, Plat Jogchum

机构信息

Department of Nutrition and Movement Sciences, Research Institute of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, P.O. Box 616, 6200 MD Maastricht, the Netherlands.

Department of Nutrition and Movement Sciences, Research Institute of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, P.O. Box 616, 6200 MD Maastricht, the Netherlands.

出版信息

Clin Nutr. 2025 Mar;46:60-71. doi: 10.1016/j.clnu.2025.01.018. Epub 2025 Jan 22.

Abstract

BACKGROUND

Different collagen hydrolysate sources have reduced fasting glucose concentrations. Although porcine-derived collagen hydrolysate predicts in vitro the highest potency for improving glucose metabolism, these effects have not been studied in humans.

AIM

To evaluate the effects of porcine-derived collagen hydrolysate on continuously monitored glucose concentrations in real-life conditions in individuals with overweight/obesity. Additionally, postprandial responses following a mixed meal test were examined.

METHODS

Fifty-six men and women participated in this randomized placebo-controlled parallel trial. After a two-week run-in period, participants consumed daily for four weeks 10 g porcine-derived collagen hydrolysate or placebo (erythritol). The primary outcome parameter was the interstitial glucose area under the curve (AUC) during daytime (07:00 to 22:00) measured during three consecutive days. In addition, glycemic variability (GV) was quantified. For this, a continuous glucose monitor (Freestyle Libre ProiQ, Wiesbaden, Germany) was used at the end of the run-in and intervention periods. Postprandial glucose, insulin, and triacylglycerol concentrations were also evaluated after a mixed meal tolerance test. Furthermore, fasting glucose, insulin, hemoglobin A1c (HbA1c), homeostatic model assessment for insulin resistance (HOMA-IR), HOMA of β-cell function (HOMA-β), and triacylglycerol changes were analyzed. Physical activity profiles and dietary intakes were monitored to exclude confounding by these lifestyle factors.

RESULTS

Collagen hydrolysate consumption did not significantly affect daytime interstitial glucose AUC concentrations (95%CI for the effect size: -5.1, 30.0 mmol/(L∗h); p-value = 0.159), but increased several GV metrics: standard deviation (95%CI: 0.0, 0.2 mmol/L; p-value = 0.011), continuous overall net glycemic action (CONGA-4) (95%CI: 0.1, 0.4 mmol/L; p-value = 0.015), coefficient of variation (95%CI: 0.1, 3.0 %; p-value = 0.036), M-value (95%CI: 0.2, 1.8; p-value = 0.036), and mean amplitude of glycemic excursions (MAGE) (95%CI: 0.2, 1.8 mmol/L; p-value = 0.036). Furthermore, the postprandial glucose AUC after the mixed meal test significantly increased (95%CI: 0, 103 mmol/L∗4-h; p-value = 0.049), as well as fasting insulin concentrations (p-value = 0.005), HOMA-IR (p-value = 0.008), and HOMA-β (p-value = 0.009). Other parameters, anthropometrics, physical activity, and energy/nutrient intakes were not significantly changed.

CONCLUSION

Four-week collagen hydrolysate intake did not change free-living glucose concentrations, but increased GV, postprandial glucose AUC, fasting insulin, HOMA-IR, and HOMA-β. However, these changes were small with limited clinical relevance. Therefore, it can be concluded that this porcine-derived collagen hydrolysate does not improve glucose metabolism or other cardiometabolic risk markers.

CLINICAL TRIAL REGISTRATION

This clinical trial was registered in November 2021 as NCT05282641.

摘要

背景

不同来源的胶原蛋白水解物可降低空腹血糖浓度。尽管猪源胶原蛋白水解物在体外预测对改善葡萄糖代谢具有最高效力,但这些作用尚未在人体中进行研究。

目的

评估猪源胶原蛋白水解物对超重/肥胖个体在实际生活条件下连续监测的葡萄糖浓度的影响。此外,还检测了混合餐试验后的餐后反应。

方法

56名男性和女性参与了这项随机安慰剂对照平行试验。在为期两周的导入期后,参与者连续四周每天服用10 g猪源胶原蛋白水解物或安慰剂(赤藓糖醇)。主要结局参数是连续三天测量的白天(07:00至22:00)期间的组织间葡萄糖曲线下面积(AUC)。此外,对血糖变异性(GV)进行了量化。为此,在导入期和干预期结束时使用了连续血糖监测仪(德国威斯巴登的Freestyle Libre ProiQ)。混合餐耐量试验后还评估了餐后血糖、胰岛素和甘油三酯浓度。此外,分析了空腹血糖、胰岛素、糖化血红蛋白(HbA1c)、胰岛素抵抗稳态模型评估(HOMA-IR)、β细胞功能稳态模型评估(HOMA-β)和甘油三酯变化。监测身体活动情况和饮食摄入量,以排除这些生活方式因素的混杂影响。

结果

服用胶原蛋白水解物对白天组织间葡萄糖AUC浓度没有显著影响(效应量的95%置信区间:-5.1,30.0 mmol/(Lh);p值 = 0.159),但增加了几个GV指标:标准差(95%置信区间:0.0,0.2 mmol/L;p值 = 0.011)、连续总体净血糖作用(CONGA-4)(95%置信区间:0.1,0.4 mmol/L;p值 = 0.015)、变异系数(95%置信区间:0.1,3.0%;p值 = 0.036)、M值(95%置信区间:0.2,1.8;p值 = 0.036)和血糖波动平均幅度(MAGE)(95%置信区间:0.2,1.8 mmol/L;p值 = 0.036)。此外,混合餐试验后的餐后葡萄糖AUC显著增加(95%置信区间:0,103 mmol/L4-h;p值 = 0.049),空腹胰岛素浓度(p值 = 0.005)、HOMA-IR(p值 = 0.008)和HOMA-β(p值 = 0.009)也增加。其他参数、人体测量指标、身体活动和能量/营养摄入量没有显著变化。

结论

四周的胶原蛋白水解物摄入并未改变日常葡萄糖浓度,但增加了GV、餐后葡萄糖AUC、空腹胰岛素、HOMA-IR和HOMA-β。然而,这些变化很小,临床相关性有限。因此,可以得出结论,这种猪源胶原蛋白水解物不会改善葡萄糖代谢或其他心脏代谢风险标志物。

临床试验注册

该临床试验于2021年11月注册,注册号为NCT05282641。

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